A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

This study has been completed.

First Received: July 1, 2005 Last Updated: October 13, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00118716

Purpose

During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.

Condition	Intervention	Phase
Activity/Exercise Induced Bronchospasm	Drug: Fluticasone propionate/salmeterol	Phase IV

MedlinePlus related topics: Asthma Exercise and Physical Fitness

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.

Secondary Outcome Measures:

Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.

Estimated Enrollment:	230
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	4 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosed with persistent asthma for 3 months or longer.
Experienced worsened asthma symptoms during physical activity.
Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

Exclusion criteria:

Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
Admitted to a hospital within the previous 6 months due to asthma symptoms.
Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.)
The study physician will evaluate other medical criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118716

Show 42 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Additional Information:

http://www.findclinicalstudy.com This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SFA100314
Study First Received:	July 1, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00118716 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

asthma
bronchospasm

Study placed in the following topic categories:

Anti-Inflammatory Agents
Spasm
Neurotransmitter Agents
Bronchial Spasm
Salmeterol
Bronchial Diseases
Adrenergic Agents
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Asthma

Anti-Allergic Agents
Adrenergic Agonists
Asthma, Exercise-Induced
Hypersensitivity
Respiratory Tract Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Spasm
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents

Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Asthma, Exercise-Induced
Autonomic Agents
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009